DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN ATORVASTATIN SOLID DOSAGE FORM AND BULK DRUGS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 12
Abstract
Objective: The present paper reports the development of simple, rapid, accurate and stability indicating reversed phase high-performance liquid chromatography method (RP-HPLC) for estimation of related substances in Atorvastatin calcium (ATV) bulk drug as well as in solid dosage form. The method was validated using Agela, Unisol C18 (250 mmX 4.6 mm; 5µ) column.Methods: A method was developed to separate clearly the drug peak from the synthetic/process impurities and degradation products formed under stress conditions is attained on (T/%B) were set at 0/43, 18/43, 20/60, 33/60, 35/43, and 40/43 of 0.02 mM ammonium acetate buffer of pH4.9 was used as mobile phase A and 90:10 v/v, ratio of acetonitrile and tetrahydrofuran was used as mobile phase B. A flow rate of 1.4 ml/min and column temperature of 25 °C was used. The wavelength selected was 246 nm. The developed method was validated as per ICH guidelines for the specificity, precision, linearity, accuracy, limit of detection, limit of quantitation and robustness.Results: Linearity of the impurities was accomplished in the range 0.3-6.0µg/ml for impurity A (Imp A), B (Imp B), C (Imp C), H (Imp H) and 0.4-6.0µg/ml for impurity D (Imp-D), correlation coefficient was found to be more than 0.999 for all impurities. Recovery of impurities was found to be in the range 93%-111%.Conclusion: The developed method was simple, precise, accurate, robust and also cost effective as it has shorter run time for quantification of impurities in drug substance and drug product as well.Â
Authors and Affiliations
Manoj Kumar Vadlamudi, Sangeetha Dhanaraj, Sanjeeva Yarkala, John Joseph Jayapal, Pavan Kumar Kommavarapu
Keywords
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- EP ID EP578054
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